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<eudamedExport entity="devices">
  <row>
    <udiDi>00606401109016</udiDi>
    <basicUdiDi>B-00606401109016</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TFI LSR Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFI-1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:51:03.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606401108033</udiDi>
    <basicUdiDi>B-00606401108033</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TGI-D Gel Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TGID-3</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:51:01.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606401108026</udiDi>
    <basicUdiDi>B-00606401108026</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TGI-D Gel Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TGID-2</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:59.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606401108019</udiDi>
    <basicUdiDi>B-00606401108019</basicUdiDi>
    <tradeName>Nagor Limited</tradeName>
    <deviceName>TGI-D Gel Filled Testicular Implant</deviceName>
    <manufacturerName>Nagor Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019179</manufacturerSrn>
    <authorisedRepresentativeName>GC Aesthetics (Management) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004118</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080201</emdnCode>
    <emdnDescription>TESTICLE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TGID-1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:58.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000366</udiDi>
    <basicUdiDi>B-00180668000366</basicUdiDi>
    <tradeName>14cm ProACT Single- INTL</tradeName>
    <deviceName>14cm ProACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800022-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:11.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000342</udiDi>
    <basicUdiDi>B-00180668000342</basicUdiDi>
    <tradeName>9cm ACT Single- INTL</tradeName>
    <deviceName>9cm ACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800021-05</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:08.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000359</udiDi>
    <basicUdiDi>B-00180668000359</basicUdiDi>
    <tradeName>12cm ProACT Single- INTL</tradeName>
    <deviceName>12cm ProACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800022-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:07.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000335</udiDi>
    <basicUdiDi>B-00180668000335</basicUdiDi>
    <tradeName>8cm ACT Single- INTL</tradeName>
    <deviceName>8cm ACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800021-04</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:51.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000328</udiDi>
    <basicUdiDi>B-00180668000328</basicUdiDi>
    <tradeName>7cm ACT Single- INTL</tradeName>
    <deviceName>7cm ACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800021-03</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:50.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000311</udiDi>
    <basicUdiDi>B-00180668000311</basicUdiDi>
    <tradeName>14cm ProACT Double- INTL</tradeName>
    <deviceName>14cm ProACT Double- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800018-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:49.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000304</udiDi>
    <basicUdiDi>B-00180668000304</basicUdiDi>
    <tradeName>12cm ProACT Double- INTL</tradeName>
    <deviceName>12cm ProACT Double- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800018-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:47.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000298</udiDi>
    <basicUdiDi>B-00180668000298</basicUdiDi>
    <tradeName>9cm ACT Double- INTL</tradeName>
    <deviceName>9cm ACT Double- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800016-05</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:45.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000281</udiDi>
    <basicUdiDi>B-00180668000281</basicUdiDi>
    <tradeName>8cm ACT Double- INTL</tradeName>
    <deviceName>8cm ACT Double- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800016-04</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:43.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000274</udiDi>
    <basicUdiDi>B-00180668000274</basicUdiDi>
    <tradeName>7cm ACT Double- INTL</tradeName>
    <deviceName>7cm ACT Double- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800016-03</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:43.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000168</udiDi>
    <basicUdiDi>B-00180668000168</basicUdiDi>
    <tradeName>6cm ACT Single- INTL</tradeName>
    <deviceName>6cm ACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800021-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:37.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000151</udiDi>
    <basicUdiDi>B-00180668000151</basicUdiDi>
    <tradeName>5cm ACT Single- INTL</tradeName>
    <deviceName>5cm ACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800021-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:36.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000069</udiDi>
    <basicUdiDi>B-00180668000069</basicUdiDi>
    <tradeName>6cm ACT Double- INTL</tradeName>
    <deviceName>6cm ACT Double- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800016-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:35.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00180668000052</udiDi>
    <basicUdiDi>B-00180668000052</basicUdiDi>
    <tradeName>5cm ACT Double- INTL</tradeName>
    <deviceName>5cm ACT Double- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800016-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:32.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003967185</udiDi>
    <basicUdiDi>8964003967Ves-342H2</basicUdiDi>
    <tradeName>POWER X Vacuum Erection System</tradeName>
    <deviceName>POWER X Vacuum Erection System</deviceName>
    <manufacturerName>VES-VACUUM INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000040378</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ves-342</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:16:19.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003967178</udiDi>
    <basicUdiDi>8964003967Ves-1314UJ</basicUdiDi>
    <tradeName>ACTIV Vacuum Erection System</tradeName>
    <deviceName>ACTIV Vacuum Erection System</deviceName>
    <manufacturerName>VES-VACUUM INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000040378</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P080202</emdnCode>
    <emdnDescription>PENILE PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ves-1314</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:16:16.424Z</lastUpdated>
  </row>
</eudamedExport>